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The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.

Detailed Description

This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Criteria for eligibility

Healthy Volunteers: No

Maximum Age: 70 Years

Minimum Age: 20 Years

Gender: Both

Criteria: Inclusion Criteria:

- 20-70 years

- Histologically proven adenocarcinoma of the stomach

- Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery

- Stage II, III (AJCC 7th edition)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- No prior chemotherapy or radiotherapy

- Adequate bone marrow, renal, and liver function

Exclusion Criteria:

- Any evidence of metastatic disease (including presence of tumor cells in the ascites).

- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.

- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.